Kinpeygo 布地奈德缓释胶囊 budesonide

Drug Class

Locally-acting corticosteroid

Mechanism

Budesonide enteric capsule is designed to release budesonide in the distal ileum targeting Peyer's patches, suppressing Gd-IgA1 antibody production to halt IgAN pathogenesis.

Approved Indication

Treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression to reduce the loss of kidney function.

What This Means For Patients

Kinpeygo/Tarpeyo (budesonide enteric capsules) is the first disease-modifying treatment approved for primary IgA nephropathy. It targets the mucosal immune system in the gut to reduce the production of IgA antibodies that damage the kidneys. It is approved in mainland China and also accessible in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2021) — label
• EMA — approved (2022) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• NefIgArd — Lafayette et al., Lancet 2023 (NCT03643965) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215935s005lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/kinpeygo
• https://doi.org/10.1016/S0140-6736(23)01554-4